The present invention relates generally to multifunctional devices for performing suction, irrigation, and manipulation at an internal site in a subject, and more particularly to enlargeable multifunctional devices for performing such functions while avoiding obstruction during conventional and endoscopic surgery.
There are two fundamental types of surgery, conventional and endoscopic surgery. Conventional surgery generally involves a relatively large incision with direct visualization (e.g. the xe2x80x9cnaked eyexe2x80x9d) of the area being operated upon. Examples of conventional surgery include heart and bowel surgeries. Endoscopic surgery involves indirect visualization of the operative field with a small camera. Endoscopic surgery is generally done by way of multiple small incisions through which a camera and instruments are inserted. The instruments perform their functions inside the body but are operated by use of their handles outside the body. Examples of endoscopic surgery include endoscopic appendix or gallbladder removal. Endoscopic surgery can also be done through existing, natural orifices (e.g. certain prostate surgeries).
A surgeon uses mechanical devices to assist in performing a variety of interventions within the surgical field during an operation. Three functions generally performed by such mechanical devices include direct tissue manipulation, irrigation, and suction. Direct tissue manipulation may include, but is not limited to, cutting, stitching, cauterizing, injecting, and scraping. Irrigation may include washing the surgical area with fluids (often directed with a tube and/or nozzle). Irrigation is employed as the area of interest within the operative field can become contaminated or can be obscured from visualization by blood or debris. Suction is employed as irrigation fluids and bodily fluids collect in the operative field and need to be removed. There are various devices that currently fulfill these functions. Their use is sometimes impeded, however, when malleable tissue such as fat or intestine surrounds the area of interest and obstructs visualization and/or operation of the device. Below are examples of the limitations of currently used devices.
Currently utilized direct tissue manipulation devices come in many different designs. These devices do not have a feature to intrinsically hold malleable tissue away from the tip of the instrument. This function is served by an assistant""s hands or a separate device. This can make surgery particularly difficult during small incision conventional surgery or any endoscopic surgery.
Currently utilized suction devices contain a tube of fixed diameter (see, e.g., FIG. 1). These devices have an opening and/or perforations on the sides of the barrel through which fluid flows and is removed from the operative field. However, during endoscopic surgery (or other types of surgery), the ability to retract tissue out of the operative field is constrained by the limited number of introducer ports through which extra instruments can be placed. Thus, suction devices are frequently operated in close proximity to malleable tissue such as fat or intestine. This leads to frequent obstructions of the suction ports which require the surgeon to disengage the tissue from the device in order to resume suctioning of fluid. Disengaging the tissue from the suction device uses valuable operating room time and distracts from the primary tasks of the operation.
Currently utilized irrigation devices simply have a tube through which fluid is expelled into the operative field for cleansing or visualization purposes. Like the other two examples, malleable tissue can obstruct the end of the instrument.
What is needed are multifunctional devices capable of performing functions at an internal site in a subject (e.g. suction, irrigation, tissue manipulation) while avoiding obstruction from malleable tissue.
The present invention relates generally to multifunctional devices for performing suction, irrigation, and manipulation at an internal site in a subject, and more particularly to enlargeable multifunctional devices for performing such functions while avoiding obstruction during conventional and endoscopic surgery.
In some embodiments, the present invention provides multifunctional devices (e.g. for performing at least one function at an internal site in a subject), comprising; an elongate member with a plurality of openings defining an enlargeable section, wherein the enlargeable section comprises a plurality of walls, and wherein the enlargeable section is movable between a non-enlarged position, and an enlarged position. In preferred embodiments, the enlarged position creates a chamber in the elongate member. In particular embodiments, the enlarged position is any position of the enlargeable section that has a cross-sectional dimension greater than the enlarged section when in the non-enlarged position. In certain embodiments, the enlargeable section, when moved from the non-enlarged position to the enlarged position, is capable of pushing bodily tissue outward (e.g. the walls of the enlargeable section are capable of pushing bodily tissue away from the elongate member axis).
In other embodiments, the present invention provides multifunctional devices (e.g. for performing at least one function at an internal site in a subject comprising; an elongate member with a plurality of openings defining an enlargeable section, wherein the enlargeable section comprises a plurality of walls, and wherein the enlargeable section is movable between a non-enlarged position, and an enlarged position, wherein the enlarged position forms a chamber in the elongate member, and b) a sleeve member enclosing at least a portion of the elongate member, the sleeve member being moveable between a first position along the elongate member that fully encloses the enlargeable section, and a second position along the elongate member that at most partially encloses the enlargeable section. In particular embodiments, the sleeve member enclosing at least a portion of the elongate member may be pushed distally around the enlargeable section to transfer the location of maximal suction and/or irrigation forces toward the distal end of the device.
In certain embodiments, the present invention provides methods for constructing a multifunctional device, comprising; a) providing an elongate member, and b) generating a plurality of openings in the elongate member such that an enlargeable section is formed in the elongate member, the enlargeable section comprising a plurality of walls and being moveable between a non-enlarged position and an enlarged position. In preferred embodiments, the enlarged position creates a chamber in the elongate member.
In other embodiments, the present invention provides methods for constructing a multifunctional device, comprising; a) providing; i) an elongate member, and ii) a sleeve member configured for enclosing at least a portion of the elongate member; and b) generating a plurality of openings in the elongate member such that an enlargeable section is formed in the elongate member, the enlargeable section comprising a plurality of walls and being moveable between a non-enlarged position and an enlarged position, wherein the enlarged position creates a chamber in the elongate member; and c) inserting the elongate member into the sleeve member such that the sleeve member is moveable between a first position along the elongate member that fully encloses the enlargeable section, and a second position along the elongate member that at most partially encloses the enlargeable section.
In some embodiments, the present invention provides methods for performing at least one function at an internal site in a subject, comprising; a) providing; i) a multifunctional device comprising an elongate member with a plurality of openings defining an enlargeable section, wherein the enlargeable section comprises a plurality of walls, and wherein the enlargeable section is movable between a non-enlarged position, and an enlarged position, wherein the enlarged position creates a chamber in the elongate member, and ii) a subject comprising a body opening; and b) inserting the multifunctional device through the body opening into an internal site in the subject with the enlargeable section in the non-enlarged position. In preferred embodiments, the method further comprises step c) moving the enlargeable section from the non-enlarged position to the enlarged position. In certain embodiments, the methods of the present invention are part of an endoscopic surgery or endoscopic procedure. In some embodiments, the moving step is accomplished by pushing the distal end of the device against a solid surface in the subject (e.g. against tissue in the subject).
In other embodiments, the device further comprises a sleeve member, and the moving step is accomplished by moving the sleeve member to a position such that it does not enclose the enlargeable section. In other embodiments, the body opening is an incision in the body of the subject. In some embodiments, the body opening is a natural orifice in the body of the subject. In particular embodiments, the sleeve member enclosing at least a portion of the elongate member may be pushed downward around the enlargeable section to transfer the location of maximal suction and/or irrigation forces toward the proximal end of the device.
In certain embodiments, the elongate member is configured for transmitting fluid (e.g. into and/or out of a surgical site). In some embodiments of the present invention, the elongate member is configured for suctioning. In other embodiments, the elongate member is configured for irrigation.
In particular embodiments, the elongate member comprises a tube (e.g. a cylindrical, hollow member with openings at both ends). In some embodiments, the tube comprises plastic (e.g., polyethylene, polypropylene, polystyrene, polyvinyl chloride, nylon, polyacetal, polyphenylene oxide, polytetrafluoethylene, polyethylene teraphthalate, polybutylene terephthalate, phenolic urea formaldehyde, melamine formaldehyde, polyester, and combinations thereof). In some embodiments, the elongate member is at least 1 centimeter in length (e.g. at least 1 centimeter, or at least 2 centimeters, or at least 3 centimeters). In certain embodiments, the elongate member is at least 5 centimeters in length (e.g. at least 5 centimeters, or at least 10 centimeters). In other embodiments, the elongate member is at least 12, or at least 15, or at least 18, or at least 20 centimeters in length. In particular embodiments, the elongate member is no more than 5 centimeters in length (e.g. no more than 5 centimeters, or no more than 3 centimeters, or no more than 2 centimeters).
In some embodiments, the elongate member has a primary cross-sectional dimension (e.g., a cross-sectional dimension that is present throughout at least 50 percent of the length of the elongate member). In certain embodiments, the primary cross-sectional dimension is present throughout at least 60 percent, or at least 70 percent, or at least 80 percent, or at least 90 percent, or at least 95 percent, or at least 99 percent of the elongate member. In preferred embodiments, the cross-sectional dimension of the elongate member is uniform throughout its length. In certain embodiments, the primary cross-sectional dimension is a diameter value ranging between 2 millimeters and 15 millimeters (e.g., approximately 2 mm, 3 mm, 8 mm, 12 mm, or 14 mm). In other embodiments, the primary cross-sectional dimension is a diameter value ranging between 4 millimeters and 10 millimeters (e.g. approximately 4 mm, 6 mm, 8 mm or 10 mm).
In particular embodiments, the elongate member comprises a distal tip. In further embodiments, the enlargeable section of the elongate member has a bulging midsection shape. In other embodiments, the elongate member has a distal end and a proximal end. In certain embodiments, distal end of the elongate member is configured to be inserted in a body opening of a subject (e.g. during endoscopic surgery). In some embodiments, the proximal end of the elongate member is configured to remain outside the body (e.g., during endoscopic surgery such that the device may be manipulated by a user, such as a surgeon). In other embodiments, the enlargeable section is located in the distal end of the elongate member. In still other embodiments, the multifunctional device further comprises a handle. In particular embodiments, the handle is located in, or attached to, the proximal end of the elongate member.
In certain embodiments, the plurality of walls are separated by at least one of the plurality of openings (e.g. at least 1, 2, 3, 4, 5, 6, 7, 8, or 9 of the plurality of openings). In other embodiments, at least one of the plurality of walls is at least 1 millimeter in length (e.g., at least 1, 2, 3, 4, 5, or 6 millimeters in length).
In some embodiments, at least one of the plurality of openings in the elongate member is a longitudinal opening. In further embodiments, the at least one longitudinal opening is at least 1 millimeter in length (e.g. at least 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, or 6 mm in length). In certain embodiments, the plurality of openings comprises at least three separate openings (e.g. at least 4, or 5, or 6, or 7, or 8, or 9, or 15, or 20 separate openings). The plurality of openings of the present invention may be of any shape or size. In some embodiments, the openings are longitudinal, diamond, zig-zag shape, regular or irregularly shaped, and allow adjustment of the chamber shape and/or volume.
In certain embodiments, the enlargeable section, when in the enlarged position, has a cross-sectional dimension at least 1.5 times larger than the enlarged section when in the non-enlarged position (e.g. at least 1.5 times larger, or at least 2 times larger, or at least 3 times larger, or at least 4 times larger). In some embodiments, the chamber has a volume of at least 5 cubic centimeters (e.g., at least 6 cc, 7 cc, 8 cc, 9 cc, or at least 10 cc).
In preferred embodiments, at least a portion of the enlargeable section is enclosed by media (e.g., an expandable membrane, such as GORE-TEX ePTFE membranes, made by W. L. Gore and Associates, Inc., Elkton, Md.). In particularly preferred embodiments, the media is biocompatible. In other preferred embodiments, the media further comprises a therapeutic agent, including, but not limited to, antibiotics, anticoagulants, steroids, and combinations thereof. In some embodiments, the media is permeable to liquid. In other embodiments, the media (e.g. latex) is impermeable to liquid. In still other embodiments, the media is partially permeable to liquids. In other embodiments, the media comprises perforations (e.g. that allow fluid to pass).
In certain embodiments, the multifunctional device further comprises an adjustment device. In other embodiments, at least a portion of the adjustment device is within the elongate member. In some embodiments, the adjustment device is configured for changing the shape of the chamber. In preferred embodiments, the adjustment device is configured for moving the enlargeable section from the non-enlarged position to the enlarged position, or vice-versa. In other embodiments, the adjustment device comprises a handle component (e.g. such that user can operate the adjustment device from outside the body of a patient).
In some embodiments, the multifunctional devices of the present invention further comprise an inner utility member. In particular embodiments, the inner utility member comprises a rod or rod-like member. In certain embodiments, the inner utility member is configured for transmitting fluid (e.g. irrigation or suction, or both). In other embodiments, the inner utility member is configured for attachment to a tissue manipulator tip (or the distal end of the inner utility member forms a tissue manipulator tip). In some embodiments, the multifunctional device further comprises a tissue manipulator tip (e.g. connected to the inner utility member).
In certain embodiments, the enlargeable section of the elongate member comprises a spring member. In some embodiments, the spring member is configured to move the enlargeable section to the enlarged position. In other embodiments, the spring member is configured to move the enlargeable section to the non-enlarged position. In other embodiments, the enlargeable section has passive spring action (e.g. will move to the enlarged position unless constrained). In some embodiments, the plurality of walls of the enlargeable section have passive spring action (e.g. will move to the enlarged position unless constrained).
In some embodiments, the multifunctional devices of the present invention comprise a sleeve member. In certain embodiments, the sleeve member encloses at least a portion of the elongate member. In other embodiments, the sleeve member is moveable (e.g. adjustable) between a first position along the elongate member that fully encloses the enlargeable section, and a second position along the elongate member that at most partially encloses the enlargeable section (e.g. at most encloses 95%, 75%, 50%, 25%, 10% or 5% of the enlargeable section). In other embodiments, the enlargeable section is in the non-enlarged position when the sleeve member is in the first position. In particular embodiments, the enlargeable section is in an enlarged position when the sleeve member is in the second position.
In certain embodiments, the sleeve member comprises plastic (e.g., polyethylene, polypropylene, polystyrene, polyvinyl chloride, nylon, polyacetal, polyphenylene oxide, polytetrafluoethylene, polyethylene teraphthalate, polybutylene terephthalate, phenolic urea formaldehyde, melamine formaldehyde, polyester, and combinations thereof).
In other embodiments, the sleeve member is configured to be moved (e.g. adjusted) from outside of a subject""s body (e.g. during endoscopic surgery). In some embodiments, the sleeve member comprises a proximal end, and the proximal end is connected to a handle.
In some embodiments, the present invention provides methods for constructing a multifunctional device, comprising; a) providing an elongate member, and b) generating a plurality of openings in the elongate member such that an enlargeable section is formed in the elongate member, wherein the enlargeable section comprises a plurality of walls. In other embodiments, after step b), the elongate member comprises a distal tip. In particular embodiments, the enlargeable section is moveable between a non-enlarged position and an enlarged position, wherein the enlarged position creates a chamber in the elongate member. In particular embodiments, the enlarged position is any position of the enlargeable section that has a cross-sectional dimension greater than the enlarged section when in the non-enlarged position. In certain embodiments, the generating comprises cutting a plurality of holes (e.g. slits) in the elongate member. In some embodiments, the present invention provides methods for constructing a multifunctional device, comprising; generating an elongate member that has a plurality of openings, wherein the plurality of openings form an enlargeable section comprising a plurality of walls. In some embodiments, the generating comprises blow-molding, or otherwise forming, the elongate member such that a plurality of openings are formed therein.
In other embodiments, the present invention provides kits, comprising an elongate member with a plurality of openings defining an enlargeable section, wherein the enlargeable section comprises a plurality of walls, and wherein the enlargeable section is movable between a non-enlarged position, and an enlarged position, wherein the enlarged position forms a chamber in the elongate member, and b) a sleeve member configured for enclosing at least a portion of the elongate member, the sleeve member being moveable between a first position along the elongate member that fully encloses the enlargeable section, and a second position along the elongate member that at most partially encloses the enlargeable section. In other embodiments, the kits of the present invention further comprise any of the additional components of the multifunctional devices mentioned above (e.g. media, inner utility member, adjustment device, elongate member with or without a distal tip, etc.). In certain embodiments, the kits of the present invention further comprise instructions for assembling and/or using the multifunctional devices of the present invention.
In other embodiments, the present invention provides systems, comprising an elongate member with a plurality of openings defining an enlargeable section, wherein the enlargeable section comprises a plurality of walls, and wherein the enlargeable section is movable between a non-enlarged position, and an enlarged position, wherein the enlarged position forms a chamber in the elongate member, and b) a sleeve member configured for enclosing at least a portion of the elongate member, the sleeve member being moveable between a first position along the elongate member that fully encloses the enlargeable section, and a second position along the elongate member that at most partially encloses the enlargeable section. In other embodiments, the systems of the present invention further comprise any of the additional components of the multifunctional devices mentioned above (e.g. media, inner utility member, adjustment device, elongate member with or without a distal tip, etc.). In certain embodiments, the systems of the present invention further comprise instructions for assembling and/or using the multifunctional devices of the present invention.
In other embodiments, the present invention provides multifunctional devices that permit the removal of bodily and irrigation fluids, the injection of irrigation fluids, or the manipulation of tissue (e.g. cautery, cutting, scraping, etc.), comprising an elongate member (e.g. suction and/or irrigation tube) that is connected to, or preferably integral with, an enlargeable section that is configured to provide access down into a surgical field (e.g. for removal or injection of fluids), the enlargeable section defining a chamber volume having an area measured across the elongate member axis similar to the cross-sectional area of the elongate member when the enlarged section is non-deployed (e.g. in a non-enlarged position), and having an area measured across the elongate member axis greater than the cross-sectional area of the elongate member, and thereby an increased chamber volume, when the enlargeable section is deployed (e.g. in an enlarged position).
In some embodiments, the enlargeable section comprises walls. In further embodiments, the wall are perforated. In certain embodiments, the wall of the enlargeable section, when deployed, are capable of pushing bodily tissue outward from the elongate member axis to form an enlarged chamber volume free of bodily tissue (e.g. such that fluids may be collected for removal).
In certain embodiments, the elongate member has a plurality of openings that form the enlargeable area. The openings may be of any shape or size. In some embodiments, the openings are longitudinal, diamond, zig-zag shape, regular, or irregular in shape, and allow adjustment of the chamber shape and volume.
In particular embodiments, the walls of the enlargeable section have passive spring action that opens the enlargeable section to its deployed shape and size. In other embodiments, the walls of the enlargeable section have passive spring action that returns the enlargeable section to its non-deployed (e.g. non-enlarged) shape and size when deployment forces are released or counteracted, whereby the chamber length can be reduced and the chamber width and volume can be increased by pushing on the tube and enlargeable section.
In some embodiments, the multifunctional device further comprises a tissue manipulation tip (including, but not limited to, a cautery tip, scalpel tip, scissors tip, scraping tip, and stitching tip) which can operate both within the enlargeable section and beyond the tip of the enlargeable section.
In further embodiments, the multifunctional device further comprises an adjustment device that connects to the enlargeable section and is operable from the top of the elongate member. In certain embodiments, the adjustment device may be used to change the change length, width and volume (e.g., change the enlargeable section from a non-enlarged position to an enlarged position, or vice versa).
In some embodiments, the multifunctional device of the present invention further comprises a sleeve member around the elongate member, through which the elongate member (e.g. tube) and enlargeable section can move. In certain embodiments, the sleeve member may be used to insert into or withdraw from the surgical area the elongate member (e.g. suction/irrigation tube), with the enlargeable section in a non-deployed (e.g. non-enlarged), or partially deployed condition. In particular embodiments, the sleeve member enclosing at least a portion of the elongate member may be pushed downward around the enlargeable section to transfer the location of maximal suction and/or irrigation forces toward the proximal end of the device.
In certain embodiments, the walls of the enlargeable section comprise tynes. In some embodiments, when the tynes are spread apart form openings between them for fluid movement. In particular embodiments, the tynes have outward or inward passive spring action to create deployment or non-deployment forces.
In some embodiments, the multifunctional device of the present invention comprises flexible media material surrounding and/or conforming to at least a portion of the enlargeable section. In certain embodiments, the flexible media serves to control movement of materials into the chamber. In other embodiments, the media is fluid permeable or impermeable, or perforated, in specific areas, thus restricting bodily tissue from entering the chamber.
In additional embodiments, the multifunctional device further comprises an inner utility member (e.g. suction and/or irrigation tube) inside of the elongate member. The inner suction/irrigation tube may be employed to additionally remove bodily or irrigation fluids or inject irrigation fluids. In other embodiments, the insertion depth of the inner suction/irrigation tube determines the zone from which fluids are removed or to which fluids are injected within the chamber.